Comparative, Randomized Study on the Anti-inflammatory and Regenerative Efficacy of a New Medical Device (DM) Based on Hydrolyzed Collagen Peptides in Patients With Femoro-acetabular Impingement Undergoing Hip Arthroscopy
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 25 people enrolled
- Started
- 28 May 2021
- Ended
- 20 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
- Cortisone
- Record updated
- 30 January 2024
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- candidates for hip arthroscopy for femoroacetabular impingement (FAI)
- ability to provide informed consent
Who cannot take part
- patients suffering from cancer or with poor general health conditions
- patients suffering from coagulation diseases
- positive history of tumor, infection, rheumatic or metabolic disease in the joint undergoing surgery
- systemic inflammatory rheumatic diseases
- patients with proven hypersensitivity to collagen of bovine origin or vitamin C
- inability to provide informed consent
- pregnant or breastfeeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Hip Osteoarthritis (HOA) is the most common joint disorder and a major cause of disability in the adult population. Thus, the early diagnosis, prevention, and treatment of the early stages of the disease and of the pre-arthritic condition, in particular in adolescents and young adults, is crucial to reducing the incidence of end-stage HOA and the need for total hip replacement (THR).
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Evidence has mounted for a prominent etiologic role of femoroacetabular impingement (FAI) in the development of early HOA leading to the development of early cartilage and labral damage in the non-dysplastic hip. Therefore, the surgical treatment of FAI with mini-invasive arthroscopy is crucial. To improve the outcome after surgery, cortisone is routinely injected during the procedure for anti-inflammatory purposes.
The aim of the study is to compare the use of cortisone (gold-standard) (C) to a new class III medical device based on hydrolysed Collagen Peptides PEP-52, Peptys (P) and to investigate potential associations among the preoperative symptoms and hip function, the outcomes after arthroscopic surgery and biomarkers in synovial fluids (SFs).
The 2 groups in the trial
- Cortisone (C)Existing treatment, for comparison
To improve the outcome of the arthroscopy during the procedure, cortisone is injected for anti-inflammatory purposes at the end of the surgical procedure.
Treatment: Cortisone
- Hydrolyzed Collagen PeptidesTreatment being tested
The use is alternative to cortisone
Treatment: Class III medical Hydrolyzed Collagen Peptides PEP-52 (Peptys)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 30 January 2024